DESCRIPTION: In response to the growing HIV epidemic in Northern Tanzania and recognizing the critical need for clinical research to address best uses of antiretrovirals and appropriate management strategies for comorbidities, we seek to develop an HIV clinical trials research unit and prepare for the submission of a CIPRA U01 grant in two years. The specific aims of this proposal are: (1) to further define characteristics of target populations for eventual antiretroviral therapy trials; (2) to formalize a collaborative HIV treatment and prevention consortium in the Kilimanjaro region and explore multi-site collaborations with HIV-investigators elsewhere in Tanzania and internationally; and (3) to train Tanzanian investigators for clinical trials design and monitoring. Each objective will be coordinated with the others so that as preliminary data are generated, research plans and collaborations will be formulated, and key young Tanzanian investigators will be trained. As this planning project progresses, individual projects and project leaders will be identified for development in the U01 application. The particular strengths of this effort include the scientific and administrative leadership of Professor John Shao at Kilimanjaro Christian Medical Centre (KCMC), a sustained track record of collegial and productive scientific collaborations with multiple international investigators, the capacity to develop infrastructure at KCMC, and a strong collaborative relationship with investigators at Duke University who have purposed to assist us in developing such a program, and in particular, in training young investigators. This proposal is further enhanced by strong complementary affiliations among KCMC and two other organizations in the Kilimanjaro Region --KIWAKKUKI, a community-based organization that provides home-based care to persons living with HIV/AIDS and is a leader in preventive efforts in the region and Kibongoto National Tuberculosis Hospital, a referral facility in which 35% of tuberculosis patients are co-infected with HIV and which has a long history of expertise in clinical trials with anti-tuberculosis regimens. This application demonstrates the extraordinary commitment and expertise already in place to expand existing infrastructure and to establish a comprehensive, multidisciplinary research program that will focus on HIV-related clinical trials, while complementing and expanding prevention efforts in our region.